About the HARMONY Type 2 Diabetes Medical Research Study

The purpose of the HARMONY study is to evaluate the safety and effectiveness of an investigational type 2 diabetes treatment that is taken once a week. The sections below provide further details about this study.

Can you tell me more about the study drug?

The investigational drug being evaluated in the HARMONY program is called albiglutide. This medication comes from a new class of drugs, which are similar to some currently approved diabetes drugs. However, albiglutide is designed to have a much longer-lasting effect.  

Some diabetes medications must be injected multiple times a day. But, researchers are hopeful that one injection of albiglutide per week will be effective in controlling type 2 diabetes.
All study participants receiving treatment with albiglutide will be given an injector pen. The study staff will show you how to use this pen at home to administer your injections.

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Would I be eligible to participate in this program?

To pre-qualify for the HARMONY study, you must be:

  • 18 years of age or older,
  • diagnosed with type 2 diabetes, AND
  • having trouble controlling your blood sugar levels.

Women who are pregnant or breast-feeding will not be allowed to participate in this study. There are additional criteria you must meet to enroll in this study.

Participants will receive study medication as well as study-related medical evaluations and tests at no cost.

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How long would my participation last?

Your total participation in the HARMONY program could last approximately 3 years, with up to 30 visits to the study clinic.

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What kind of medical tests and evaluations are involved with this study?

During the clinic visits, you will undergo a series of evaluations to monitor your safety and progress. These evaluations will include, but not be limited to:

  • physical exams
  • vital signs measurements (height, weight, blood pressure, pulse rate)
  • electrocardiograms (ECGs), which record the electrical activity of the heart
  • blood and urine samples
  • review of your medical history
  • pregnancy test (only for women of child-bearing age)
  • fasting blood sugar profile

In addition, you will be asked to use an at-home blood glucose meter (glucometer) to check your blood sugar levels on a regular basis. Study doctors will review the glucometer readings to monitor your safety and progress.

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What if I experience hyperglycemia?

An FDA, EMEA and Asia/Pacific approved diabetes drug will be available at all times during this study, in the event that you experience hyperglycemia (high blood sugar). Your study doctor will provide you with more information.

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What are the potential risks of participating in this study?

As with any medical research study, there are some risks associated with participation. It is possible that you could experience a side effect caused by the study drug. The side effect could be one that is common and known, like nausea or loss of appetite. Or, you could experience a side effect that has never been seen before.

What are the potential benefits of participating in this study?

It is also possible that you could benefit by participating in this study. You may see improved control of your type 2 diabetes as well as weight loss, although this cannot be guaranteed. At the very least, the study staff will provide you with useful advice on how to help control your diabetes through diet and exercise, and you will receive expert medical attention and diagnostic tests at no cost.

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What if I have more questions?

If you have questions about the study medication or about this medical research in general, please contact the study staff. They are available to answer all of your questions.


Pre-Qualify